E4300 Basic Surgical Pack 3-Laminate E4300

GUDID 00816953027434

Surgical gown, single-use

Primary Device ID	00816953027434
NIH Device Record Key	7e35de48-7bf6-458e-8718-6fdacf5b0759
Commercial Distribution Status	In Commercial Distribution
Brand Name	E4300 Basic Surgical Pack 3-Laminate
Version Model Number	E4300
Catalog Number	E4300
Company DUNS	014464314
Company Name	EXACT MEDICAL MANUFACTURING, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00816953027434 [Primary]

FYA	Gown, Surgical

Steralize Prior To Use	false
Device Is Sterile	true

16975424195988 - Exact Medical Manufacturing, Inc.	2025-04-07 General Purpose Probe Cover (3D End), Gel, Bands 6" x 48"
16975424195995 - Exact Medical Manufacturing, Inc.	2025-04-07 C-Arm Drape Miniview 6600/6800, 48 x 84"
06975424196001 - Exact Medical Manufacturing, Inc.	2025-04-07 General Purpose Probe Cover 5" x 48" (13cm x 122cm)
16975424196015 - Exact Medical Manufacturing, Inc.	2025-04-07 Intraoperative Probe Cover w/ Gel 5" x 96" (13cm x 244cm)
26975424196067 - Exact Medical Manufacturing, Inc.	2025-04-07 Microscope Cover Mitaka MM51
26975424196074 - Exact Medical Manufacturing, Inc.	2025-04-07 Microscope Drape For Zeiss OPMI 41" x 80"
16975424196084 - Exact Medical Manufacturing, Inc.	2025-04-07 Microscope Drape- Zeiss MD 112x300cm - 44"x118"
26975424196098 - Exact Medical Manufacturing, Inc.	2025-04-07 Intraoperative Large T-Shaped Probe Cover w/ Gel 6" x 96"